The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions

• ClinicalTrials.gov Identifier: NCT00814970
• Recruitment Status: Completed
• First Posted: December 25, 2008
• Results First Posted: May 21, 2014
• Last Update Posted: April 13, 2016
• Sponsor: Medtronic Endovascular
• Information provided by (Responsible Party): Medtronic Endovascular

Tracking Information

• First Submitted Date: December 23, 2008
• First Posted Date: December 25, 2008
• Results First Submitted Date: April 22, 2014
• Results First Posted Date: May 21, 2014
• Last Update Posted Date: April 13, 2016
• Study Start Date: November 2008
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 22, 2014)

• Major Adverse Event (MAE) Rate [ Time Frame: 12 Months ]
  Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization.
• Primary Patency Rate [ Time Frame: 12 Months ]
  Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS).

• Original Primary Outcome Measures (submitted: December 24, 2008): MAE and Primary Patency Rates [ Time Frame: 12 Months ]

Current Secondary Outcome Measures (submitted: October 9, 2014)

• Major Adverse Event (MAE) Rate [ Time Frame: 30 days ]
  Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 30 day timepoint.
• Major Adverse Event (MAE) Rate [ Time Frame: 6 Months ]
  Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 6 month timepoint.
• Device Success [ Time Frame: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient). ]
  The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.
• Lesion Success [ Time Frame: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient). ]
  The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard percutaneous devices.
• Procedure Success [ Time Frame: At time of deployment to time of hospital discharge ]
  The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related Major Adverse Events (MAE) prior to hospital discharge.
• Assisted Primary Patency [ Time Frame: 12 months ]
  Defined as vessel patency resulting from a procedure performed in the treated segment.
• Secondary Patency Rate [ Time Frame: 12 Months ]
  Defined as vessel patency resulting from any procedure that restores patency.
• Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category [ Time Frame: 12 months ]
  Improvement in Rutherford class by ≥ 1 category increase at 12 months from pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).
• Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15 [ Time Frame: 12 Months ]
  Increase in ABI/TBI ≥ 0.15 at 12 months from pre-procedure. An increase in ABI/TBI of 0.15 or greater is considered by clinicians to be a significant improvement.
• Change in Quality of Life - Decrease in Rutherford Class >= 1 Category [ Time Frame: 30 Days ]
  Decline in Rutherford class ≥ 1 category at 30 days when compared to pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).
• Percentage of Participants Free From Strut Fractures [ Time Frame: 12 Months ]
  Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up.
• Clinically-driven Target Lesion Revascularization (TLR) Rate [ Time Frame: 12 Months ]
  Defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by: a change (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI >= 0.15
• Major Adverse Event (MAE) Rate [ Time Frame: 24 Months ]
  Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 24 month timepoint.
• Percentage of Participants Free From Strut Fractures [ Time Frame: 24 Months ]
  Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 24 month timepoint.
• Major Adverse Event (MAE) Rate [ Time Frame: 36 Months ]
  Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 36 month timepoint.
• Percentage of Participants Free From Strut Fractures [ Time Frame: 36 Months ]
  Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 36 month timepoint.

Original Secondary Outcome Measures (submitted: December 24, 2008)

• MAE rate [ Time Frame: 30 days, 6 months, 24 months, 36 months ]
• Assisted Primary Patency [ Time Frame: 12 months ]
• Stent Integrity [ Time Frame: 6, 12, 24, 36 Months ]
• Acute success (device, lesion, procedure) [ Time Frame: post procedure ]
• Change in quality of life [ Time Frame: 36 months ]
• All-cause mortality [ Time Frame: 30 days ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions
• Official Title: The Complete® SE SFA Study: The Medtronic Complete Self-Expanding SFA Stent System for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and/or Proximal Popliteal Arteries
• Brief Summary: To evaluate the safety and efficacy of the Complete SE SFA Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).
• Detailed Description: The Complete Self-Expanding (SE) SFA Stent is designed to be a permanent implant. It is cut from a nickel titanium alloy (Nitinol) tube and consists of a series of segments each connected to the next in a unique pattern to allow for flexibility and vessel conformability. Each segment consists of two struts and a crown (Figure 1). It is designed to produce optimal luminal diameter and increased scaffolding, and to maintain luminal patency.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Peripheral Vascular Disease

Intervention

Device: Complete SE Vascular Stent System

Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).

Study Arms

Experimental: Complete SE Vascular Stent System

COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.

Intervention: Device: Complete SE Vascular Stent System

• Publications *: Laird JR, Jain A, Zeller T, Feldman R, Scheinert D, Popma JJ, Armstrong EJ, Jaff MR; Complete SE Investigators. Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial. J Endovasc Ther. 2014 Apr;21(2):202-12. doi: 10.1583/13-4548R.1.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 2, 2010): 196
• Original Estimated Enrollment (submitted: December 24, 2008): 178
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Rutherford 2-4, with an occlusion or de novo and/or restenotic SFA/PPA lesion ≥50% and ankle-brachial index/toe-brachial index (ABI/TBI) <0.90/0.80.
2. Target lesion located at least 1 cm distal to the take-off of the profunda femoris artery and at least 3 cm proximal to the highest point of the cortical margin of the femur;
3. Target vessel reference diameter is ≥4.0 mm and ≤7.0 mm (visual estimate);
4. Target lesion length is ≥4.0 cm and ≤14.0 cm (visual estimate);
5. Adequate distal run-off to the ankle in the target limb (defined as having at least one patent calf vessel <50% stenosed;

6. Life expectancy >12 months.

   Exclusion Criteria:

7. Women who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment;
8. Any condition that precludes safe access with percutaneous transluminal angioplasty (PTA) devices, such as: excessive peripheral artery disease, unresolved fresh thrombus in the target lesion/vessel, or a target lesion/vessel that is excessively tortuous or calcified;
9. Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
10. Previous treatment to the target lesion within the 3 months prior to enrollment; previous femoropopliteal bypass in target vessel; previous stenting of the target lesion;
11. Target lesion located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion;
12. Target lesion requires treatment other than standard PTA prior to stent placement (i.e., no other devices or procedures such as cutting balloons and laser atherectomy are permitted to be used during the index procedure);
13. History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
14. Known impaired renal function, defined as creatinine >2.5 mg/dl;
15. Known platelet count <80,000 cells/mm3 or >700,000 cells/mm3;
16. Known white blood cell (WBC) of <3,000 cells/mm3;
17. Participation in another investigational device or drug study and has not completed the primary endpoint(s) or which clinically interferes with the Complete SE SFA Study endpoints, or previously enrolled in the Complete SE SFA Study.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00814970
• Other Study ID Numbers: IP105; IDE G080143 ( Other Identifier: FDA )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Medtronic Endovascular
• Study Sponsor: Medtronic Endovascular
• Collaborators: Not Provided

Investigators

• Principal Investigator: John Laird, MD; University of California, Davis
• Principal Investigator: Dierk Scheinert, PD; Park-Krankenhaus Leipzig-Sudost GmbH

• PRS Account: Medtronic Endovascular
• Verification Date: February 2016